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Prescribing CRESTOR
Use in Specific Populations
CRESTOR® (rosuvastatin calcium) may be an effective cholesterol management option for a variety of hyperlipidemic patients.
In this section, you can review results from comparative clinical trials in which CRESTOR was used as an adjunct to diet in African-American and Hispanic-American patients.
Initiation of CRESTOR therapy with 5 mg once daily should be considered for Asian patients.
For detailed clinical trial data, select the appropriate tab below. Click on the "+" and "—" signs to expand and collapse the clinical information.
Eligible patients can pay as low as $3‡ for each prescription of CRESTOR‡‡Subject to eligibility. Restrictions apply. Click here for eligibility information.
LDL-C reductions vs atorvastatin in Hispanic-American adults with CHD, CHD risk equivalent, or a 10-year CHD risk score ≥10% and hypercholesterolemia2
Adapted from the STARSHIP Trial
LDL-C reductions vs atorvastatin in Hispanic-American adults with CHD, CHD risk equivalent, or a 10-year CHD risk score ≥10% and hypercholesterolemia2
Adapted from the STARSHIP Trial
LDL-C reductions vs atorvastatin in Hispanic-American adults with CHD, CHD risk equivalent, or a 10-year CHD risk score ≥10% and hypercholesterolemia2
*P<.0001 vs atorvastatin 10 mg, P=NS CRESTOR 10 mg vs atorvastatin 20 mg.
†P<.0001 vs atorvastatin 20 mg.
Mean baseline LDL-C: 159 mg/dL to 165 mg/dL.
CRESTOR 10 mg n=174
atorvastatin 10 mg n=161
CRESTOR 20 mg n=167
atorvastatin 20 mg n=161
TRIAL DESCRIPTION:
Adapted from the STARSHIP trial.2 STARSHIP was a 6-week, randomized, open-label, comparative, multicenter study. Following a 6-week dietary lead-in period, 696 Hispanic-American adults with CHD, CHD risk equivalent, or a 10-year CHD risk score ≥10% and hypercholesterolemia were randomized to 1 of 4 arms: CRESTOR 10 mg or 20 mg or atorvastatin 10 mg or 20 mg once daily for 6 weeks. The primary end point was the percentage change in LDL-C from baseline at 6 weeks.
NCEP ATP III LDL-C Goal Attainment <100 mg/dL in high-risk* Hispanic-American adults2,3
Adapted from the STARSHIP Trial
NCEP ATP III LDL-C Goal Attainment <100 mg/dL in high-risk* Hispanic-American adults2,3
Adapted from the STARSHIP Trial
NCEP ATP III LDL-C Goal Attainment <100 mg/dL in high-risk* Hispanic-American adults2,3
*CHD or CHD risk equivalent (other atherosclerotic disease, diabetes, 10-year CHD risk score >20%).
†P=.001 vs atorvastatin 10 mg; P=NS CRESTOR 10 mg vs atorvastatin 20 mg.
‡P<.0001 vs atorvastatin 20 mg.
Mean baseline LDL-C: 156 mg/dL to 166 mg/dL.
CRESTOR 10 mg n=116
atorvastatin 10 mg n=106
CRESTOR 20 mg n=106
atorvastatin 20 mg n=106
The statistical comparison of rosuvastatin versus atorvastatin in goal attainment was a post-hoc analysis from the STARSHIP trial.
TRIAL DESCRIPTION:
Adapted from the STARSHIP trial.2 STARSHIP was a 6-week, randomized, open-label, comparative, multicenter study. Following a 6-week dietary lead-in period, 696 Hispanic-American adults with CHD, CHD risk equivalent, or a 10-year CHD risk score ≥10% and hypercholesterolemia were randomized to 1 of 4 arms: CRESTOR 10 mg or 20 mg or atorvastatin 10 mg or 20 mg once daily for 6 weeks. The primary end point was the change in LDL-C at 6 weeks. The percentage of patients achieving NCEP ATP III LDL-C goal of <100 mg/dL was a secondary end point.
3143524-3097604 Last Updated 7/15
Important Safety Information for CRESTOR® (rosuvastatin calcium) Tablets
- CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers
- Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with statins, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg)
- CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age ≥65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir) or colchicine
- Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing CRESTOR
- There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Treatment with immunosuppressive agents may be required. Consider risk of recurrent IMNM carefully prior to initiation of a different statin, and monitor for signs and symptoms of IMNM if a different statin is reinitiated.
- It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. All patients treated with CRESTOR should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including CRESTOR. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with CRESTOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart CRESTOR
- CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease
- CRESTOR significantly increased INR in patients receiving coumarin anticoagulants. In patients taking coumarin anticoagulants and CRESTOR concomitantly, INR should be determined before starting CRESTOR and frequently enough during early therapy to ensure that no significant alteration of INR occurs
- Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking CRESTOR 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, dose reduction should be considered for patients on CRESTOR therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing
- Increases in HbA1c and fasting serum glucose levels have been reported with statins, including CRESTOR. Based on clinical trial data with CRESTOR, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus
- In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%)1,2
- Rare post-marketing reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) have been associated with statin use, including CRESTOR. These reports are generally nonserious and reversible upon statin discontinuation
- CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg
Indications
- CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels
- CRESTOR is indicated to reduce the risk of myocardial infarction, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease
Read full Prescribing Information 
(PDF - 152k) 
References
- Faergeman O, Hill L, Windler E, et al; on behalf of the ECLIPSE Study Investigators. Efficacy and tolerability of rosuvastatin and atorvastatin when force-titrated in patients with primary hypercholesterolemia. Cardiology. 2008;111(4):219-228.
- Lloret R, Yčas J, Stein M, Haffner S; STARSHIP Study Group. Comparison of rosuvastatin versus atorvastatin in Hispanic-Americans with hypercholesterolemia (from the STARSHIP trial). Am J Cardiol. 2006;98(6):768-773.
- Data on File, 267725, AstraZeneca Pharmaceuticals LP.
Lipitor is a registered trademark of Pfizer Inc.
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CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan. CRESTOR is a registered trademark of the AstraZeneca group of companies.
©2018 AstraZeneca. All rights reserved. 3143524-3097604 Last Updated 7/15